Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurity levels were detected at the 24-month time point.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Pfizer Inc. is recalling 820 cartons of Cleocin Phosphate (clindamycin phosphate) injection, USP, 600 mg/4 mL. The affected product is distributed in 4 mL vials, with 25 vials per carton. The recall covers lots T78191 (expiration 04/2019) and T97494 (expiration 07/2019).
The recall was initiated because high out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point. This indicates that the product failed to meet established impurity/degradation specifications.
The affected product was distributed nationwide in the USA and in Guam. Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
- Brand
- CLEOCIN PHOSPHATE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antibiotic Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: T78191
- Exp.04/2019
- T97494
- Exp.07/2019
Distribution
Part of a larger recall action
This product is one of 6 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same brand · CLEOCIN PHOSPHATE
- LowPfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
FDA (Drugs) · 2019-04-10
- ModeratePfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
FDA (Drugs) · 2019-04-10
- SeverePharmacia Recalls Cleocin Phosphate Vials Due to Glass Delamination
FDA (Drugs) · 2013-06-26
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Similar recalls
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